Putting sleep apnoea to bed with 3D mouthguard

A new 3D printed mouthguard is set to end the suffering for thousands of sleep apnoea patients.

The Challenge

Solving sleep problems with 3D printing

Sleep apnoea occurs when the air passage in the throat becomes blocked during sleep and causes people to stop breathing.

The CSIRO-developed mouthguard for aiding sleep apnoea sufferers

The CSIRO-developed mouthguard for aiding sleep apnoea sufferers

In severe cases, people can suffer hundreds of events per night.

An estimated one million Australians suffer from the disorder, which can lead to high blood pressure, stroke, irregular heartbeats, heart attacks and diabetes. This number is expected to increase due to growing obesity levels and an aging population.

Traditional treatments can be problematic for patients, with issues such as chronic jaw pain, teeth loosening, teeth wear, ongoing adjustment or nasal obstruction causing many to stop wearing their device.

Better treatments that overcome these limitations would benefit the growing number of sleep apnoea sufferers worldwide.

Our Response

Teaming up with dental experts to deliver

Using a 3D scanner to map a patient's mouth, our researchers and Australian dental company, Oventus , can now print a mouthpiece which prevents dangerous pauses in breath during sleep.

Printed from lightweight titanium and coated with a medical grade plastic, the breakthrough mouthpiece is customised for each patient.

The world-first device has a 'duckbill' which extends from the mouth like a whistle and divides into two separate airways. It allows air to flow through to the back of the throat, avoiding obstructions from the nose, the back of the mouth and tongue.

The device is effective as a standalone technology or can be connected to a continuous positive airway pressure machine for more advanced treatment.

The sleep scientists will be recording the patient’s body position, their air flow, the respiratory effort, their oxygen levels,

[Image shows a female putting sensors on to Dr. Ivan Cole’s head and then the camera zooms in on Dr. Ivan Cole’s face]

they’ll also be looking at brain activity and heart activity to determine stages of sleep as well

[Images move through of Dr. Ivan Cole laying down on the bed and sleeping, a female looking at a computer, the computer screen display, the female’s face and the computer screen display again]

and the last part of that puzzle is actually a visual recording, to record the patient’s sleep visually to ascertain exactly what’s happening and when.

[Image changes to show Dr. Chris Hart showing the Oventus to Dr. Ivan Cole and then the image shows Dr. Ivan Cole looking at the Oventus]

So Ivan, here’s the device.

[Camera zooms in on the Oventus and then the image changes to show Dr. Chris Hart talking to Dr. Ivan Cole]

We have this 3-D printed titanium airway here, that at night allows the air, if you’re not getting enough air through your nose, if the congestion or resistance is building up we can add to that airflow by breathing through the device as well.

[Camera zooms in on the Oventus and then the image changes to show a facing view of Dr. Chris Hart talking to Dr. Ivan Cole]

So, the air enters here. It’ll travel through the appliance in an enclosed airway and it just exits back there behind the last tooth straight into the back of the throat. So, if the nose is congesting we can continue to get air through what we call the second nose.

[Image shows a facing view of Dr. Jeremy Goldin talking to Dr. Ivan Cole and then the camera zooms in on Dr. Ivan Cole’s face and then the image changes to show Dr. Ivan Cole snoring]

Compared to other appliances, Oventus would be useful in a patient who has nasal obstruction or is a mouth breather.

[Image changes to show a model of a mouth in front of a computer screen and then the camera pans up to show the male holding the model of the mouth]

Dr Chris Hart: So, once we have the patient’s records,

[Image changes to show the model of the mouth being rotated in the hand and the diagram on the computer screen rotates in the same way]

the digital record of the patient’s mouth is uploaded on to the proprietary software

[Image changes to show a male working at a computer]

and from there we customise a design for the patient,

[Image changes to show a male walking down a Lab corridor and then the image changes to show the male’s face]

based on their anatomy and maximising air flow to the back of the throat.

[Images move through of the computer screen display, hands on the keyboard, the computer screen display, the male operating the computer and the male walking through a corridor to the 3-D printer]

Once the design file has been finalised it’ll be converted to a file that will be transferred to the 3-D printer

[Images move through of a hand inserting a chip into the machine, a computer screen, the male operating the machine and a hand on the keyboard]

and then the 3-D printer will print that file, along with around 50 to 60 other files at the same time.

[Images move through of a model mouth, two males looking at computers, the male’s faces and a model mouth on a computer screen display]

If we combine the proprietary software that we developed with the CSIRO, with the ability to print in three dimensions that’s a massive advantage.

[Images move through of a male wheeling a bin down a corridor, pouring liquid into a machine, operating the machine, putting his hand into the machine and spraying and then buffing the device on a spinning wheel]

It’s been incredibly helpful to be able to locate our premises within the CSIRO at Clayton and next to Lab 22. I mean, they are obviously world leaders in 3-D printing and handling titanium and we’ve worked with them on the development of the technology. So, to have their support on a commercial venture, producing devices that are going to patients is a massive benefit for us.

[Image changes to show a facing view of a female and then images move through of the female packaging the device into a box and then into an Oventus pack with cleaners]

So, once the devices have finished being printed and polished in Melbourne at the CSIRO, we’ll obviously make sure that they comply with our quality standards. We then manufacture the polymer parts of the device that engage the teeth.

[Image changes to show the female stacking the Oventus packages on a shelf and then the image changes to show Dr. Ivan Cole walking along the front of the sleep clinic building]

They’re then packaged with some cleaning tablets, a sonic cleaner, patient instructions and a key to adjust the device and then shipped to the clinician for delivery to the patient.

[Image changes to show Dr. Ivan Cole at the reception desk of the clinic and then the image changes to show Dr. Chris Hart shaking hands with Dr. Ivan Cole and then taking him to an office]

So, approximately three or four weeks since we saw Ivan last time, Ivan’s now returning to pick up his device. See how he goes.

[Image shows a facing view of Dr. Ivan Cole looking at the Oventus device and then the image shows a facing view of Dr. Chris Hart talking]

So Ivan, I’ve got your device here. What I’ll do now is I’ll just try this in and make sure it fits.

The Results

The Oventus Clearway Device is now available to patients in Australia through Oventus clinics, as a more effective and comfortable alternative to current products on the market.

In clinical trials, the Oventus Clearway Device showed a 50 to 90 per cent reduction in Apnoea Hypopnea Index (or API, which indicates the severity of sleep apnoea) in 75 per cent of patients. It was found to be more effective than other oral appliances and has an effect on oxygen levels comparable to continuous positive airway pressure technology.

Following these successful trial results, Oventus plans to take the device to the rest of the world, targeting the growing number of moderate to severe sufferers of sleep apnoea.

The Oventus Clearway Device retails for about $1,700 with rebates available from private health insurers.

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